• The Journal of KAIRB
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• v.5 no.2
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• pp.59-59
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• 2023

• Progress in Medical Physics
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• v.24 no.4
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• pp.205-212
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• 2013

Recent developments of image guided radiation therapy (IGRT), especially the On Board Imaging (OBI) system and the cone beam CT (CBCT), enable the radiation treatment more accurate and reliable. IGRT is widely used in the radiation therapy as a standard of care. Use of IGRT is even expected to increase in the near future. IGRT is only beneficial to patients when it is used with proper considerations of safety and appropriateness of the techniques. Institutional procedure should be developed based on the clinical need and the deep understanding of the system before applying the new technique to the clinic. Comprehensive QA program should be established before to the clinic and imaging dose should be considered when preparing the departmental practice guidelines for IGRT.

• The Journal of KAIRB
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• v.4 no.2
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• pp.23-29
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• 2022

The goal of the military medicine is not as same as that of the civil medical practice, and consequently the characteristics of military biomedical researches have their own uniqueness. In front of the prerogative of national defense, some of the human rights ordinarily ensured in normal researches with human subjects are not to be fully guaranteed. The hierarchic system of the military would complicate the issue when the soldiers are enrolled as human subject for the research. Some researches could be classified as a military secret, therefore, the confidentiality issues need to be well addressed. Institutional Review Board and review procedure should be modified for the military purposes. So, it is necessary to establish the appropriate regulatory system for the military biomedical researches with human subject to manage the complicated issues involved in them.

• The Journal of KAIRB
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• v.5 no.1
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• pp.21-32
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• 2023

Purspose: The purpose of this study is to examine the meaning and definition of vulnerable subjects in clinical trials in light of domestic and international regulations and guidelines, to analyze the contents of standard operation procedures (SOPs) among advanced general hospitals in Korea that conduct clinical trials, and to examine deliberation procedures for operation plans. Methods: The study examined how vulnerable research subjects were defined and described in related regulations and the classification of vulnerable research subjects presented in the IRB/HRPP SOPs of 18 clinical trial institutions, including 11 AAHRPP-accreditated general hospitals in Korea, as well as the operation of the IRB deliberation. Results: Among all domestic and international regulations and guidelines, only the The Council for International Organization of Medical Sciences (CIOMS) guidelines explain why vulnerability is related to judgments on the severity of physical, psychological, and social harm, why individuals are vulnerable, and for what reasons. However, the classification of vulnerable subjects by institutions differed from the classification by the International Conference on Harmonization-Good Clinical Practice (ICH-GCP). A total of the 16 institutions classified children and minors as vulnerable research subjects. 14 institutions classified subjects who cannot consent freely were classified as vulnerable subjects. 15 institutions classified sujects who can be affected by the organizational hierarchy were classified as vulnerable subjects. Subjects in emergency situations were regarded as vulnerable research subjects in 8 of institutions, while people in wards, patients with incurable diseases, and the economically poor including the unemployed were categorized as vulnerable research subjects in 7, 4, and 4 of institutions, respectively. Additionally, some research subjects were not classified as vulnerable by ICH-GCP but were classified as vulnerable by domestic institutions 15 of the institutions classified pregnant women and fetuses as vulnerable, 11 classified the elderly as vulnerable, and 6 classified foreigners as vulnerable. Conclution: The regulations and institutional SOPs classify subjects differently, which may affect subject protection. There is a need to improve IRBs' classifications of vulnerable research subjects. It is also necessary to establish the standards according to the differences in deliberation processes. Further, it is recommended to maintain a consistent review of validity, assessment of risk/benefit, and a review using checklists and spokeperson. The review of IRB is to be carried out in a manner that respects human dignity by taking into account the physical, psychological, and social conditions of the subjects.

• Journal of Arbitration Studies
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• v.19 no.2
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• pp.3-26
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• 2009

This paper is to research on the role of party autonomy in the decision of applicable law for the arbitral proceeding, arbitral award and arbitration agreement, in the decision of the place of arbitration, in the composition of arbitration tribunal, and the choice of arbitral proceedings. The principle of party autonomy is fundamental to arbitration in general and to international arbitration in particular. Generally the tenn of party autonomy is used as the autonomy of the parties to decide all aspects of an arbitration procedure subject only to certain limitations of mandatory law. Party autonomy permits the parties to a commercial arbitration to choose the laws and make the rules which govern the arbitral proceedings. Party autonomy allows the parties freedom to choose the applicable laws for the arbitral proceeding and the place of arbitration. Party autonomy is recognized in relation to the choice of law for the merits of the dispute as well as for the arbitration agreement and the arbitration procedure. On the basis of the recognition of party autonomy in international treaties, national legislation and court decisions, arbitral practice has generally accepted and enforced party autonomy both regarding the procedure and the applicable substantive law. All modern institutional rules of arbitration follow that line. Today it is recognized by national legislators all over the world to the effect that the jurisdiction of national courts can be excluded by arbitration agreement and that the parties may choose the law applicable to arbitral proceedings. Limits on party autonomy are imposed by mandatory provisions of international or national law or of institutional arbitration rules regarding the procedure. Mandatory laws at the place of the arbitration or under any procedural law chosen by the parties may restrict party autonomy. These mandatory laws usually take the form of public policy considerations in the arbitration. Limitations on party autonomy have been reduced more and more, and the trend of modern national as well as international legislation on arbitration leans clearly in the direction of a maximum of party autonomy.

• Asian Journal of Business Environment
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• v.11 no.1
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• pp.5-15
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• 2021

Purpose: The study aims to delineate Shariah Governance Framework (SGF) by applying the components of New Institutional Theory (NIT) to provide an understanding of how Islamic banks theoretically influence Shariah Governance (SG) practice, structure, and process. Design/methodology/approach: As it is a conceptual paper, this paper has prepared based on an analytical approach to show how such institutions could provide a more effective system concerning the contents, procedures, and practices for the multiple users in the SG process of Islamic banks. Findings: The paper critically explores the adoption of NIT to develop SGF with its existing practice, structure, and procedure. Utilizing NIT, a proposed theoretical framework has developed for exploring the SG through its major components, i.e., 'isomorphism' and 'legitimacy'. It is stated that NIT can offer a useful framework by which homogenous structures, comprising guidelines, standards, and practices become recognized and authorized as a satisfactory standard corporate exercise. Thus, the proposed theoretical framework would be beneficial in understanding and exploring the SGF. Conclusion: The application of this SGF could help to justify the key dimensions of NIT with its overall formation, function, and practices that might also help to attain legitimacy.

• Journal of Environmental Impact Assessment
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• v.5 no.1
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• pp.1-13
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• 1996

This paper examined public participation in the final Environmental Impact Statement(EIS) in terms of institutional procedures and content analysis. By reviewing EIS Draft Manual and related laws and regulations, seven problems were identified in the system. The content of public participation in 14 EISs were analyzed by a developed protocol, most results of which were similar to the identified seven problems. In conclusion, this paper suggested that the systematic problems should be improved to activate more efficient public participation.

• Journal of Korean Society of Disaster and Security
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• v.15 no.4
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• pp.1-9
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• 2022

This study analyzes the institutional status related to 'evacuation' and 'firefighting' in underground subway stations, derives institutional limitations for 'evacuation' in underground subway stations, and proposes guidelines in terms of architectural space based on this. As a result of the study, the following points were derived. First, since similar standards are separately enacted in individual laws and it is difficult to grasp the standards and they are dualized, it is necessary to standardize and regulate the space where users stay according to the movement of urban railway users, limited to urban railways. Second, in order to use trains, a special procedure called 'ticketing' must be considered, and regulations on evacuation safety zones and evacuation stairs between the waiting room and the platform are required. Finally, if there is a platform at a depth of more than 30m underground, it is necessary to install an evacuation floor in accordance with standards similar to the current building law.

• The Journal of KAIRB
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• v.6 no.2
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• pp.48-55
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• 2024

Purpose: The purpose of this study is to introduce the Institutional Review Board (IRB) member-based internal audit method performed at A University Hospital, a secondary medical institution, and to identify the differences in audit results according to the characteristics of each auditor and the factors affecting the internal audit results. Furthermore, we will find out what needs to be improved in the internal audits to achieve Quality assurance (QA) objectives for human subject research conducted in medical institutions. Methods: The auditors were divided into group A (IRB member belonging to institution A) and group B (clinical trial QA administrator belonging to other institutions) and independently inspected the 2 studies using the same internal audit checklist (consisting of 11 domains, 130 items), and the differences in the internal inspection checklists written by each auditor were compared and analyzed. Results: In the case of audit for the study 1, the number of missing checklists is 1 for group A and 0 for group B, and the number of the matters to be pointed out is 1 for group A and 12 for group B. In the case of audit for the study 2, the number of missing checklists is 2 for both A and B, and the number of points is 5 for A and 4 for B. The differences in the internal audit results written by each auditor that the authors verified are summarized as follows. First, there were more comments from group B auditor than from group A auditor. Second, the results may vary because each auditor has different criteria for evaluating the appropriateness of an item. Third, there are cases where the questions on the checklist are vague or the definition is not clear, so they have the same opinion but check it with different answers. Fourth, if the auditors make a mistake when filling out the checklist, it causes to led to different the results. Conclusion: We propose the following items that should be improved in order to conduct consistent and efficient internal audits. First, it is necessary to test the tool in order to carry out reliable and consistent internal audits. Second, it is necessary to complete specialized training related to internal audit before conducting internal audit. Third, before notifying the audit results, it is necessary to have a procedure or a final review system to check whether the audit contents are appropriate. Fourth, Institutional support is needed to recruit specialized personnel for internal audits.

• Korean Security Journal
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• no.43
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• pp.231-257
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• 2015

Today, the international community make every effort to suppress security crimes, to provide numerous institutional strategies and to prevent security crimes such as the terrorism and spy. Particularly, developed countries in the field of security are strengthening related legislation under new-security conditions. Things work a little differently about security crimes because the nation's benefit and protection of the law is the basis of individual benefit and protection of the law under investigation procedure of the security crimes. Therefore they have policy that permits major investigative agency under the arrest and detention procedure(e.g. security and communication monitoring ${\ldots}$). Criminal procedure's improvement and reinforcement are very important for events related security. But, The investigation procedure between criminal offense and security crimes makes no odds in the Korea. Continuance of such a national mood will accuse of not responding appropriately in preparation for new-security conditions recently. To revise with international best security legislation, We should institute a proper registration system in Korea's situation. This study have been discussing how to improve related legislation under new-security conditions through the cases analysis of the arrest and detention procedure in Korea.